This is a CLIA-waived system. Policies and Procedures Manual

Transcription

1 This is a CLIA-waived system. Policies and Procedures Manual

2 Approval date Approved by Reviewed/Revised: Date By whom Title Roche Diagnostics 9115 Hague Road Indianapolis, IN COAGUCHEK is a trademark of Roche. Dispatch is a registered trademark of Caltech Industries, Inc. Vacutainer is a registered trademark of Becton, Dickinson and Company. All other product names and trademarks are property of their respective owners Roche Diagnostics. All rights reserved (04)

3 Table of Contents POLICIES AND PROCEDURES... 1 Overview... 1 Principle of Operation... 2 Roche Diagnostics Technical Service Center... 2 Test Strip Storage and Handling... 3 PURPOSE... 3 POLICY Test Strip Storage and Handling... 3 Coding the Meter with the Test Strip Code Chip... 4 PURPOSE... 4 POLICY Coding the Meter with the Test Strip Code Chip... 4 PROCEDURE Matching Code Chip to Test Strip... 4 PROCEDURE Inserting the Test Strip Code Chip... 5 Setting up the CoaguChek XS Plus System... 6 PURPOSE... 6 POLICY Setting up the System... 6 PROCEDURE Setting up the System... 7 Patient Preparation... 8 PURPOSE... 8 POLICY Patient Preparation... 8 PROCEDURE Patient Preparation... 8 Specimen Collection and Handling... 9 PURPOSE... 9 POLICY Specimen Collection and Handling... 9 POLICY Rejecting Specimens... 9 POLICY Blood Application PROCEDURE Direct fingerstick and capillary tube sample collection Testing a Patient Sample PURPOSE PROCEDURE Testing a Patient Sample Interpreting Test Results PURPOSE POLICY Interpreting Test Results PROCEDURE Interpreting Test Result Documenting Test Results PURPOSE POLICY Documenting Test Results PROCEDURE Documenting Test Results Quality Control Testing PURPOSE POLICY Liquid Quality Control Testing POLICY Liquid Control Storage and Handling POLICY Documenting Liquid Quality Control Testing Results PROCEDURE Preparing a Liquid Quality Control i

4 PROCEDURE Liquid Quality Control Testing Calibration and Calibration Verification PURPOSE POLICY Calibration and Calibration Verification Evaluation Protocol PURPOSE POLICY Evaluation Protocol POLICY Testing Precision Using Liquid Controls PROCEDURE Testing Precision Using Liquid Controls PROCEDURE Steps to Calculate QC Precision POLICY Method Comparison PROCEDURE--Method Comparison Using Direct Fingerstick or Capillary Tube Samples 32 PROCEDURE--Performing the Method Comparison Using Venous Blood POLICY Proficiency Testing Limitations of the Method PURPOSE LIMITATIONS Cleaning the Meter PURPOSE POLICY Cleaning and Disinfecting the Meter PROCEDURE - Cleaning/disinfecting the meter housing (the exterior of the meter) PROCEDURE - Cleaning/disinfecting the meter test strip guide Recommendations for Operator Certification/Recertification PURPOSE POLICY Recommendations for Operator Certification and Recertification Additional Facility policy References OPERATOR IN-SERVICE CURRICULUM Introduction Training Materials Supplies Class Orientation Training DVD Understanding the System Reviewing Operating and Storage Conditions Setting Up the System Test Strip Code Chip Set-up Options Preparing for the Test Testing a Patient Sample Patient Test Results stored in memory Responding to Results Practicing and Confirming Optional Quality Control Testing Control Test Results stored in memory ii

5 Cleaning the System POLICY Cleaning and Disinfecting the Meter Review the following policy for cleaning and disinfecting the meter Troubleshooting Concluding the Session Knowledge Test Certificate of Completion Log Sheets Operator Certification Log Instrument Log Reagent Log Patient Test Log Quality Control Log Quality Control Chart Quality Control Chart Preventive Maintenance Log Temperature Log Skills Checklist Performance Evaluation Knowledge Test Precision Data Log for Liquid QC Method Comparison Log iii

6 POLICIES AND PROCEDURES For use with the CoaguChek XS Plus System. Overview Introduction The CoaguChek XS Plus System measures blood-clotting time (prothrombin time, or PT) for people who are taking anticoagulation medications, such as Coumadin or warfarin. The CoaguChek XS Plus System measures bloodclotting time using blood from the fingertip or whole blood from a vein (nonanticoagulated venous whole blood). The CoaguChek XS Plus System quantitatively measures prothrombin (blood-clotting) time (PT/Quick value/inr). INR is a measure of the rate at which blood clots. A low INR can increase the risk of blood clots, while a high INR can increase the risk for internal bleeding. The patient s physician will determine the best INR range for that patient, depending on why the patient is taking anticoagulants and how the patient reacts to them. The doctor will also determine how often the patient needs blood testing. The system includes the CoaguChek XS Plus meter, CoaguChek XS PT test strips and optional liquid CoaguChek XS Pro PT Controls. The meter guides you through the test step by step using the symbols and instructions in the display. Each box of test strips has its own code chip that you insert into the meter. The code chip contains lot-specific information about its test strips, such as the expiration date and calibration data. Controls are made available to assist with regulatory compliance requirements as applicable to this facility. Clinical Laboratory Improvement Amendments 1988 (CLIA 88) Requirements As of September 2012, the CoaguChek XS Plus System is CLIA waived. Intended use Roche Diagnostics is pleased to present CoaguChek XS Plus System Policies and Procedures to assist you in developing policies and procedures to ensure quality care with prothrombin testing and in implementing regulations of CLIA 88 in your own facility. 1

7 Principle of Operation Use The CoaguChek XS PT Test strip, used as directed with the CoaguChek XS Plus meter, provides accurate blood PT values. Test principle The CoaguChek XS PT Test, used as directed with the CoaguChek XS Plus meter, will provide an electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin. In simple terms, blood works with the chemicals in the test strip to make a small electric current in the test strip that measures blood clotting time. WHO reference In 1983, the World Health Organization (WHO) adopted this calibration system and made recommendations for its implementation to allow all thromboplastins of varying sensitivity in any laboratory for oral anticoagulant control to be calibrated against a reference thromboplastin of human brain with an ISI of Roche Diagnostics Technical Service Center If you have questions, please contact your account manager, or call Roche Diagnostics Technical Service Center at , available 24 hours a day, 365 days a year. We offer assistance in Spanish and many other languages. 2

8 Test Strip Storage and Handling PURPOSE The following policy is intended to help operators with correct strip handling and storage. If you are new to the CoaguChek XS Plus System, watch the CoaguChek XS Plus System DVD and read the CoaguChek XS Plus System Getting Started Guide before testing. Ingredients Each CoaguChek XS PT test strip contains reagent (human recombinant thromboplastin 1.5 U), stabilizers, preservatives, and additives. POLICY Test Strip Storage and Handling Strips are intended for in vitro diagnostic use only. Exercise normal precautions when handling laboratory reagents. Follow your facility s infection control guidelines. Store the test strips in their container with the cap closed. You can store the test strips at room temperature or in the refrigerator (36 F to 86 F or 2 C to 30 C). When stored properly, the test strips can be used until the expiration date printed on the test strip container. When you are ready to test, open the test strip container and remove one strip from the container. Immediately close the container. Make sure it seals tightly. Dispose of the test strips if they are past their Use By date. Use the test strip within 10 minutes after removing it from the container. Do not open a vial of test strips or touch a test strip with wet hands or gloves. This may damage the test strips. Close the container tightly. 3

9 Coding the Meter with the Test Strip Code Chip PURPOSE The following procedures provide instructions for matching the code chip to the test strip lot and changing the test strip code chip. The test strip code chip provides the meter with important information that it needs to perform the coagulation test. The chip contains information about the test method, the lot number and the expiration date. POLICY Coding the Meter with the Test Strip Code Chip The test strip code chip is required when a new test strip container is opened to store the lot information about the test strips in the meter. The CoaguChek XS Plus meter stores the data from up to 60 code chips. Use the test strip code chip that was supplied with each new test strip container before you perform the first test. Leave the code chip in the meter to protect the electrical contacts in the meter from becoming dirty. Each code chip belongs to a particular lot of test strips. Only remove the code chip when you are testing with test strips taken from a new pack (with a new code chip). Protect the code chip from moisture and equipment that produces magnetic fields. PROCEDURE Matching Code Chip to Test Strip 1. Before each test, make sure the correct code chip is in the meter. 2. The 3-number code on the test strip container must match the 3-number code on the code chip. 3. To install the code chip, follow the instructions below. Have the code chip ready. 4

10 PROCEDURE Inserting the Test Strip Code Chip 1. Be certain the meter is OFF. 2. Remove the old code chip if there is one inserted in the meter. Store the code chip with appropriate strip lot. 3. Insert the code chip into the code chip slot in the meter with the printed side facing UP until it snaps into place. Always compare the code number you see on the display with the number that is printed on the test strip container you are using. If the two code numbers do not match, insert the correct code chip in the slot in the meter. If the code chip is missing or incorrectly inserted, error messages appear in the display. (Please refer to the chapter Error Messages in the CoaguChek XS Plus System User Manual.) 5

11 Setting up the CoaguChek XS Plus System PURPOSE The following policy and procedure provides instructions for setting up the CoaguChek XS Plus system. POLICY Setting up the System The setup of the CoaguChek XS Plus meter is the responsibility of manager, nursing supervisor, qualified operator, etc.) The following set up selections are established when setting up the meter: (Select box(es) below by right clicking, then select properties. Then select Checked under Default Value.) (who? lab Screen Options ID Setup Contrast (0-10) Result Units INR INR/SEC INR/%Q Language Selection Date (format) Time (format) Sort display results by Date and Time Patient ID Beeper Tone Off On Low Medium High Key Click On Off Auto Off Off (meter never turns itself off.) Time until meter turns itself off (minutes) Computer (connection requires optional software) Active Inactive Admin. Operator ID Patient ID No Optional Mandatory Alphanumeric Numeric Max Length (1-20) Characters 6

12 Lockouts Operator Lockout (only available with optional software) New Code Yes No No Weekly Monthly Every three months Every six months Annually Quality Control No Daily Weekly Monthly One level Two levels PROCEDURE Setting up the System The procedures for setting up the meter can be found in the CoaguChek XS Plus System User Manual. Note: If you have not set the date (after turning the meter on for the first time or because the batteries were removed from the meter for more than 10 minutes), you cannot perform a test. In that case, turning on the meter takes you immediately to the SETUP mode, where you must set the date and time. Once the date and time are set, the meter automatically moves to the main menu, where you can start a test or enter more settings. The next time you turn the meter on, the date and time will remain and you will automatically go to the main menu. 7

13 Patient Preparation PURPOSE The following policy and procedure provides instruction for preparing a patient for testing on the CoaguChek XS Plus System. POLICY Patient Preparation Before performing the test, the operator explains to the patient the purpose and steps of the procedure. Observe universal precautions based on the compliance program of this facility. Exercise precautions required for handling all blood specimens and laboratory reagents. Operators must wash hands before and after testing. Operators must wear disposable gloves when collecting blood samples or performing tests. If possible, have patients wash hands prior to testing. Dispose of used test strips, lancets, and venipuncture supplies in the appropriate designated biohazard or sharps containers. PROCEDURE Patient Preparation 1. Explain the purpose and steps of the testing procedure to reassure the patient. 2. Wash your hands and put on disposable gloves prior to testing. 3. Collect blood sample following the procedure in the Specimen Collection and Handling section below. 8

14 Specimen Collection and Handling PURPOSE The following policies and procedures provide instructions for collecting, handling, and rejecting patient test specimens. POLICY Specimen Collection and Handling The CoaguChek XS Plus System test may be performed with fresh capillary whole blood from a fingerstick or fresh venous whole blood drawn in an anticoagulant-free plastic syringe. The results are unaffected by heparin concentrations up to 0.8 U/mL. The CoaguChek XS PT Test is insensitive to low molecular weight heparins (LMWH) up to 2 IU anti-factor Xa activity/ml. The test strip must be used within 10 minutes of removing from it from the container. The meter should display the flashing test strip and blood drop symbols prior to sample collection. Capillary sample must be applied to the strip within 15 seconds of the fingerstick. Minimum sample size is 8 µl of blood. Use of single-use CoaguChek Lancets (REF ), available from Roche Diagnostics, is recommended. POLICY Rejecting Specimens Plasma or serum CANNOT be used as a testing sample. Sample size CANNOT be less than 8 µl. Venous sample CANNOT be collected in a syringe containing anticoagulant. Sample must be USED IMMEDIATELY after collection. Glass tubes or glass syringes CANNOT be used (only use plastic). Additional blood sample CANNOT be added to the test strip once testing has begun. When a patient is on intravenous infusion therapy, sample CANNOT be collected from arm receiving the infusion line. See the package insert for additional limitations to the procedure. 9

15 POLICY Blood Application Apply directly from the finger to the test strip or use the CoaguChek Capillary Tubes/Bulbs (REF ), or apply directly from the needle of a plastic syringe filled with blood sample. Read the testing instructions in the CoaguChek XS Plus System User Manual and the CoaguChek XS Plus PT Test Insert before collecting the sample. PROCEDURE Direct fingerstick and capillary tube sample collection 1. Gather the following: CoaguChek XS Plus meter CoaguChek XS PT Test strips and matching code chip CoaguChek Lancet or other lancet device Alcohol wipe or soap and water Gauze or cotton ball Bandages 2. Prepare lancet device according to manufacturer s instructions. Set it aside until fingerstick is needed. 3. If using the CoaguChek Capillary Tubes/Bulbs (REF ), prepare capillary collection device by firmly inserting the capillary tube into the capillary bulb. Set aside until needed 4. Warm the hand. Have the patient hold it under his or her arm, use a hand warmer, or wash with warm water. 5. Have the patient let that arm hang down by his or her side before lancing a finger. 6. Massage the finger from its base DO NOT MILK THE FINGER. 7. Clean the selected finger with alcohol wipe or use soap and warm water. Allow to air dry completely. 8. When the meter displays the flashing test strip and blood drop symbols, with the hand still down, stick the side of finger with a lancet. DO NOT WIPE AWAY THE FIRST DROP OF BLOOD. DO NOT puncture the finger until the flashing test strip and blood drop symbols appear on the meter screen. 9. Immediately after lancing, massage gently along the side of the finger to obtain a good blood drop without pressing or squeezing too hard. 10. While the flashing test strip and blood drop symbols appear on the display, apply the first drop of blood (within 15 seconds) as outlined in Testing a Patient Sample. 10

16 Hold the blood drop to the strip until the meter beeps (providing beeper is set to ON). DO NOT apply a second drop or disturb the strip while testing. 11. If using the CoaguChek Capillary Tubes/Bulbs, touch the capillary tube to the blood drop. Keep tube level and allow it to fill halfway by capillary action. Put finger over hole in the capillary bulb. Hold capillary tube directly over sample target area. While the test strip and blood drop symbols are flashing on the display, apply the sample within 15 seconds of the puncture as outlined in Testing a Patient Sample. Note: Avoid getting air bubbles into the sample. Do not touch the bulb during sample collection. If blood gets into the capillary bulb during sample collection, discard the bulb. PROCEDURE Venous Sample Collection 1. Prepare a plastic syringe that is free of anticoagulants. Syringe needle should be 23 gauge or larger. A 21-gauge or larger needle is recommended. 2. When the meter displays the flashing test strip and blood drop symbols, perform the venipuncture. 3. Draw venous sample into the plastic syringe. 4. While the meter displays the flashing test strip and blood drop symbols, apply sample as outlined in Testing a Patient Sample. 11

17 Testing a Patient Sample Note: Medical staff and other persons using the CoaguChek XS Plus meter to perform tests on more than one patient must be aware that any object coming into contact with human blood is a potential source of infection (See: Clinical and Laboratory Standards Institute: Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline -Third Edition; CLSI document M29-A3, 2005). Refer to the user manual for guidance on the cleaning and disinfection of the meter system. PURPOSE The following policy and procedure provides instructions for testing a patient sample. POLICY Testing a Patient Sample Only a certified operator may perform a test with the CoaguChek XS Plus System. Tests are performed with the CoaguChek XS Plus System only in response to written or electronic requests from an authorized person. Oral requests are permitted only if the facility obtains written authorization for testing within 30 days. Because of the hazards of handling blood products, wear disposable gloves when collecting specimens and performing test procedures. Observe and use universal precautions for all blood specimens. Handle at Biosafety Level 2 as recommended for any potentially infectious material in the Centers for Disease Control/National Institutes of Health manual, Biosafety in Microbiological and Biomedical Laboratories, Refer to this facility s infection control procedures for proper disposal of bloodcontaminated items in compliance with OSHA and CDC regulations for universal precautions. 12

18 PROCEDURE Testing a Patient Sample 1. Prepare the lancet device or venipuncture supplies according to the manufacturer s instructions. 2. Place meter on a flat surface, free of vibrations. Or hold it in your hand horizontally until you see the test result. Do not move the meter around during testing. 3. Take a test strip out of the container. Close the container tightly. 4. Hold the test strip so the lettering CoaguChek XS PT is facing upward. 5. Slide the test strip into the test strip guide in the direction indicated by the arrows. 6. Slide the test strip in as far as it will go. This turns the meter ON. A beep tone indicates that the meter has detected the test strip (provided the beeper is turned on in the settings). For alternative ways of turning on the meter, please refer to the CoaguChek XS Plus System User Manual. 7. Check the battery level. If there are no bars left in the battery symbol, you cannot perform any more tests. 8. Check that the date and time are correct. Correct any wrong entries as described in the CoaguChek XS Plus System User Manual. If a lockout (OP. or QC Lockout) is displayed instead of PATIENT TEST, you must run a quality control before you can perform a test. (Refer to Quality control in the User Manual.) When the meter is in lockout status, a test cannot be performed. 9. Enter your operator ID (if required). See CoaguChek XS Plus System User Manual. 10. Touch [OK] to log on and move to the main menu. 11. Touch PATIENT TEST. 12. Select or enter Patient ID (if required). See CoaguChek XS Plus System User Manual for information on Operator lists. 13. Touch [OK]. An hourglass symbol indicates the test is warming up. 14. Confirm that the code number displayed on the meter matches the number on the test strip container. The meter automatically checks to see if you have the right test strip code chip. The 3 digit code on the test strip vial must match the number on the test strip code chip before a test can be run. 13

19 15. The blood drop symbol flashes to indicate that the meter is ready to perform the test and is waiting for blood to be applied. The 180-second count down begins. DO NOT perform fingerstick until the flashing drop of blood appears on the display. Strip must be used within ten minutes of removing it from the container. 16. Identify the sample target area on the test strip. 17. Collect the fingerstick or venous blood sample as outlined below. Fingerstick sample DO NOT wipe away the first drop of blood. Apply the first drop of blood to the top or side of the target area within 15 seconds of puncture. Hold the blood drop to the test strip until you hear a beep (provided the beeper is set to ON ). Using the Capillary Tube Touch the CoaguChek Capillary tube to the blood drop. Keep tube level and allow it to fill halfway by capillary action. Put finger over hole in the capillary bulb. Hold capillary tube directly over sample target area and expel sample within 15 seconds. Note: Use the first drop of capillary blood. Avoid getting air bubbles into the sample. Venous Sample Expel the first four drops of blood from the syringe or syringe needle. Then, immediately place one drop of blood (at least 8 μl) directly onto the target area of the test strip, being sure not to introduce air bubbles into the sample. Note: Expel the first four drops of venous blood. 18. Apply the blood directly to the semicircular, transparent sample application area of the test strip. 19. You hear a beep tone when you have applied enough blood (provided the beeper is turned on). The blood drop symbol disappears and the test starts. Note: DO NOT add more sample. DO NOT touch the test strip or move the meter until the result is displayed. 20. The meter automatically performs a two-level, on-board quality control test on the test strip before it displays the test result. QC appears in the display. 21. Following a successful outcome of the quality control test, a check mark appears after QC. 22. You must WAIT for results this takes about one minute 23. The result is displayed in the unit of measure you chose when setting up the meter. It is automatically saved to memory. 14

20 24. Read and record results. 25. After the test results are displayed, a strip and arrow symbols appear on the screen, prompting you to remove the strip. If you would like to add a comment to the result, you must do so BEFORE you remove the test strip from the meter. 26. Remove the test strip from the measurement chamber. 27. Turn meter OFF. 28. Dispose of all biohazardous material in the appropriate designated biohazard or sharps container. Note: Use a new fingerstick from the opposite hand and a new test strip if you must retest. DO NOT add more blood to the first test strip. 15

21 Interpreting Test Results PURPOSE The following policies and procedures assist you with interpreting test results. Before interpreting the result, please also read the test strip package insert carefully. POLICY Interpreting Test Results Expected Results: Any unexpected results should always be followed up with an immediate call to the attending physician. A Panic Value is a PT INR result that is above or below the Immediate Follow-up Values set by the physician. Panic Values should always be followed up with an immediate call to the physician. The CoaguChek XS Plus meter displays test results in units equivalent to laboratory plasma measurements. Results may be displayed in three ways: International Normalized Ratio (INR=(PT/Mean Normal PT)) INR/SEC (Seconds) INR/% Quick (a unit used mainly by healthcare professionals in Europe). Each lot of test strips is calibrated to a reference lot that is traceable to the WHO International Reference Preparations. Normal INR levels vary from person to person. For the purpose of providing universal INR results, the Mean Normal Prothrombin Time (MNPT) has been established as 12 seconds and the ISI for the system has been established as 1.0. The physician must determine the best INR level depending on the reason for anticoagulant treatment and how each individual responds to treatment (based on Prothrombin Time). Each physician should establish expected values for his or her patient population or individual patients. Differences in reagents, instruments, and pre-analytical variables can affect prothrombin time results. These factors should be considered when comparing different prothrombin time test methods. 1 Experience comparing results obtained using the CoaguChek XS Plus System to those obtained using common clinical 16

22 laboratory reagents shows that the CoaguChek XS Plus System correlates well with the following clinical laboratory reagents: Dade Innovin, Ortho Recomboplastin, and Dade Thromboplastin C+. Note: It s possible other clinical laboratory reagents may not consistently correlate with the CoaguChek XS Plus System as well as the recommended list above. Unusual Results: Certain drugs may affect results by interfering with warfarin pharmacology. The potential effect of a drug interaction with warfarin or the effect of underlying diseases (e.g. liver disease, congestive heart failure) must be considered when interpreting a result. Changes in the patient s diet can cause unusually low or high results. Any unusual result can be followed up with inquiries to define the cause of the unusual result. If the result does not match the clinical symptoms, repeat the patient test to rule out procedural error. PROCEDURE Interpreting Test Result 1. If the meter displays a message other than a result, refer to the Error Messages section of the CoaguChek XS Plus System User Manual. 2. If a < 0.8 INR or > 8.0 INR is displayed, the test result could not be measured or the result may be outside the measuring range for the particular lot of test strips. Repeat the test with a new strip and a new fingerstick. Refer to this facility s policy on Unusual Results. Note: In rare cases, an error message can occur in patients with long coagulation times (> 8 INR). If this error message appears again when the test is repeated, the result must be checked using another method. 3. If the meter displays an unusual test result (other than an error message), check the following items: Check that the correct code chip is in the meter. The 3-number code on the test strip container must match the 3-number code on the code chip. Check that the meter is set up with the correct date and time. The expiration date of the strips is programmed into the code chip, and is compared to the date on the meter. Therefore, it is important that the date and time be programmed correctly on the meter. 4. Debris on the test strip guide can cause problems with results. Clean the meter as recommended in the CoaguChek XS Plus System User Manual. Do not use a spray to clean the guide or any part of the meter. Do not let liquid enter the meter 5. See the test strip package insert for the measurement range of the system and Limitations of Procedure. 17

23 Documenting Test Results PURPOSE The following policy and procedure provides instructions for documenting test results. The test result is displayed in the unit of measure you chose when setting up the meter. It is automatically saved to memory. If the memory is full when you perform a test, the oldest result is automatically deleted. The most recent result is always saved. In the memory display, you can scroll through additional results or return to the main menu. POLICY Documenting Test Results The date, time, initials of the operator, patient name, patient ID (if required) and result are examples of data that can be recorded on the patient chart or the appropriate log for your facility. The appropriate log and data to record for this facility is. Test requisitions, test authorizations, and test results are retained for a minimum of years. Linking the patient test with the appropriate CoaguChek XS Plus meter and test strip lot number creates an audit trail. A Patient Test Log is available at the back of this manual. PROCEDURE Documenting Test Results 1. Record data per this facility s policy on the patient chart or other appropriate log. 2. Any unusual result can be followed up with inquiries to define the cause of the unusual result. If the result does not match the clinical symptoms, repeat the patient test to rule out procedural error. 18

24 Quality Control Testing Your CoaguChek XS Plus system performs many types of quality control tests independently: A check of the electronic components and functions every time the meter is turned on. A check of the expiration date and lot information on the test strip. A quality control function is incorporated into the test strip. A two-level, on-board quality control test and patient result determination within a single test chamber. PURPOSE Ingredients The following policies and procedures provide instructions for performing and documenting optional liquid quality control testing. Roche Diagnostics has made available optional liquid quality controls for the CoaguChek XS Plus System. These controls are made available to assist with regulatory compliance requirements as applicable to this facility. These instructions should be read thoroughly before using the liquid controls. Each control bottle contains non-human plasma with varied levels of coagulation factors, stabilizers, and preservatives. Each diluent-filled dropper contains a calcium chloride solution with preservatives. POLICY Liquid Quality Control Testing Read control instructions thoroughly before using the controls. If you are using test strips from a new unopened container, you will need to change the test strip code chip. (The meter recognizes only those test strips that match the test strip code chip.) NOTE: The meter automatically checks to see if you have the right test strip code chip. The 3 digit code on the test strip container must match the number on the test strip code chip before a test can be run. To install the test strip code chip, follow the instructions in the CoaguChek XS Plus System User Manual. Refer to the CoaguChek XS Plus System User Manual for more details about the components and procedures of the CoaguChek XS Plus System The CoaguChek XS Plus meter displays the control range and the result. The reading is automatically saved in the memory of the CoaguChek XS Plus meter. Acceptable CoaguChek XS Pro PT Controls ranges are displayed on the meter when each Quality Control test is run. The system is working properly and all handling has been done correctly when the test results obtained are within the acceptable control range. 19

25 If a quality control test result is within the acceptable control range, it is appropriate to proceed with patient testing. Unacceptable Control Results: An out-of-range result is indicated by an arrow. An arrow pointing up means the result is too high. An arrow pointing down means the result is too low. To resolve out-of-range results or error messages, check for the following: Controls may be expired or stored improperly. The control may not have been used within 30 minutes of reconstitution. You may not be doing the test correctly. Repeat the control test, using a new test strip. Carefully follow the instructions in the User Manual. Make sure you run the test within 10 minutes of removing the test strip from its container. If you follow all these guidelines and your results are still unacceptable, call Roche Diagnostics Technical Service at The appropriate quality control frequency for this facility is (be sure to meet all standards of your regulatory agencies). Additional Facility policy (You may insert your facility s guidelines here and on the following pages.) 20

26 POLICY Liquid Control Storage and Handling For in vitro diagnostic use. Do not take internally. Exercise the normal precautions required for handling all laboratory reagents. Store controls in refrigerator at 36 F to 46 F (2 to 8 C). DO NOT FREEZE. Unopened, lyophilized controls that are stored in the refrigerator are good until the expiration date. Discard any outdated controls. Controls are stable for 30 minutes after adding the diluent. Additional requirements by the appropriate licensing or accrediting body should be incorporated into the quality control program. In this facility additional requirements are. POLICY Documenting Liquid Quality Control Testing Results Liquid quality control records are retained years, according to this facility s policy. All quality control results, along with any corrective action to restore that result to the acceptable range, are recorded on a quality control log. This log includes the test strip lot number and expiration dates, control solution lot number and expiration dates, meter serial number, control ranges, operator identification, and date the test was performed. An appropriate authority or an appointed individual reviews the liquid quality control log for completeness, and notes any trends that indicate potential problems. Such trends include: gradual drifting of values, sudden shifts in control values while using the same lot of strips, and differences in operator performance. The liquid quality control log is reviewed (When? Weekly, monthly, quarterly). An audit trail links the liquid control test with the appropriate CoaguChek XS Plus meter, test strip lot, and control solution lot used for quality control testing. Quality control testing information is also traceable to patient test results. Additional Facility policy: (You may insert your facility s guidelines here and on the following pages.) 21

27 PROCEDURE Preparing a Liquid Quality Control 1. Gather Supplies CoaguChek XS Plus meter CoaguChek XS PT Test strip(s) with matching test strip code chip CoaguChek XS Pro PT Controls: Level 1 and/or 2 with matching quality control code chip Diluent dropper(s): one for each control to be run Scissors 2. Insert the quality control code chip into the meter. This tells the meter the acceptable ranges for this box of controls. 3. Remove the screw-cap and rubber stopper from the quality control bottle. Label the bottle with the date and time that you reconstitute it. 4. Using scissors, cut off the tip of the dropper at the end of the stem. Hold the dropper a safe distance from your face. CAUTION: To avoid loss of diluent, hold the dropper by the stem; do not squeeze the bulb of the dropper while cutting the tip. 5. Invert the dropper and place the tip into the bottle. 6. Gently squeeze the bulb to dispense all of the contents of the dropper over the dried material. Do not allow the dropper to touch the dried material. IMPORTANT: Make sure you dispense ALL the diluent. 7. Remove the dropper from the bottle. DO NOT discard the dropper. Replace the cap first and gently swirl the bottle to dissolve the quality control. Do not shake or invert the quality control. Make sure that all control material is completely dissolved before you test it. 8. Use the reconstituted quality control within 30 minutes from the time the diluent is added. PROCEDURE Liquid Quality Control Testing 1. Place the meter on a flat surface, free of vibrations. Or hold it in your hand so it is roughly horizontal. Do not move the meter during testing. 2. When you are ready to test, remove one test strip from the container and immediately close the container. Make sure it seals tightly. IMPORTANT: Do not open a container of test strips or touch a test strip with wet hands or gloves. This may damage the test strips. 22

28 3. Use the test strip within 10 minutes of removing it from the container. Otherwise, you may get an error message and you will have to repeat the test. 4. Hold the test strip so the lettering is facing upward. 5. Slide the test strip into the test strip guide in the direction indicated by the arrows. 6. Slide the test strip as far as you can into the meter. This turns the meter ON. A beep tone indicates that the meter has detected a test strip (provided the beeper is turned on in the settings). For alternative ways of turning on the meter, please refer to the CoaguChek XS Plus System User Manual. 7. Check the battery level. If there are no bars left in the battery symbol, you cannot perform any more tests. 8. Check that the date and time are correct. Correct any wrong entries as described in Meter setup/setting the date of the CoaguChek XS Plus System User Manual. 9. Touch CONTROL TEST. 10. The meter automatically checks to see if you have the right test strip code chip. The three-digit code on the test strip container must match the number on the test strip code chip before the test can be run. 11. If you are using a new test strip lot and have not inserted the test strip code chip yet, you must do so now. 12. Select the code already stored for your current control solution, or touch NEW CODE to use a new control solution. Note: When you first run your control, the QC TEST screen will not display. This screen will display the next time you use the control. 13. If you are using a new control solution, remove the code chip from the meter and insert the code chip that came with the control solution instead. 14. Select level for this control test measurement. (L1 or L2) 15. The hourglass symbol shows that the test strip is warming up. 16. The dropper symbol flashes to indicate that the meter is ready to perform the test and is waiting for the control solution to be applied. A 180-second countdown begins. You must apply the control sample within this time. Otherwise, you will receive an error message. 17. When the meter is ready for the sample, gently swirl the control bottle once or twice to mix the control solution. DO NOT mix the solution with the dropper. 18. Draw control solution into the dropper and put one drop of the liquid on the top of the target area (clear area of the test strip). DO NOT add 23

29 more control. DO NOT touch or remove the test strip while the test is in progress. 19. The flashing dropper symbol changes to an hourglass symbol when the meter detects a sufficient sample. You hear a beep tone when you have applied enough control solution (provided the beeper is turned on). The dropper symbol disappears and the test starts. 20. You must WAIT for results this takes about one minute. 21. The result of the quality control is displayed. It is automatically saved to memory. 22. The acceptable range of results for the liquid control is displayed below the current result. 23. If any control remains in the dropper after you dose the test strip, return the remaining control material to the control bottle. Save extra control until after the test result is obtained, in case the control test needs to be repeated. 24. Record the result. After you verify the validity of the control result, discard the test strip, dropper and the reconstituted bottle of quality control. 25. If the quality control test fails, an up arrow (too high) or down arrow (too low) flashes on the display. 26. If you need to repeat a test, use a new test strip. 27. Remove the quality control code chip and store it with the opened box of controls. Re-insert the test strip code chip if necessary. 28. Turn the meter OFF. 24

30 Calibration and Calibration Verification PURPOSE The following policy provides information on calibration for the CoaguChek XS Plus System. Definitions: Calibration is the process of setting the instrument to provide correct answers. This is usually done by analyzing known standards supplied by the manufacturer. Linearity testing defines the limits of accuracy, which is known as the reportable range. This is usually tested with another series of known standards with a wide range of values. Calibration verification was introduced by CLIA 88 and is defined as, The assaying of calibration materials in the same manner as patient sample to confirm that the calibration of the instrument, kit, or test system has remained stable throughout the reportable range for patient test. (CFR 42 Section ). This calibration verification process determines the reportable range so it replaces the concept of linearity testing. POLICY Calibration and Calibration Verification CoaguChek XS Plus System users are already in compliance with CLIA 88 calibration requirements because the code chip supplied with each box of test strips automatically calibrates the meter for that particular lot of strips. The code chip provides specific performance characteristics information to the meter so it is calibrated for use with its corresponding specific lot of test strips and controls. The manufacturer establishes the performance characteristics based on testing of specimens from donors on warfarin therapy. Each code chip is verified to show that it will produce expected results. In addition, every time the meter is turned on, it goes through a series of self-diagnostic checks. Roche Diagnostics tests extensively to be sure calibration data provides analytical values that correspond to established reference methods. The CoaguChek XS Plus System calibration is traceable to the WHO International Reference Preparations. The CoaguChek XS Plus System cannot be adjusted externally to fit a certain linearity curve. Additional facility policy: (You may add any additional policies and procedures for this facility here.) 25

31 Evaluation Protocol (Optional) PURPOSE The following policies and procedures provide information on this facility s evaluation protocol for accuracy and precision using method comparison and liquid controls. POLICY Evaluation Protocol If desired, or if required by an accreditation agency, verify the performance specifications of the CoaguChek XS Plus system If an evaluation is performed, results must meet the standards of the facility. In this facility: Acceptable precision (%CV) is. Acceptable mean bias in INR for method comparison is. POLICY Testing Precision Using Liquid Controls A within-run precision study can be performed using 20 control samples (ten of Level 1 and ten of Level 2, tested on the CoaguChek XS Plus meter with test strips from the same lot). Before testing, set the meter to report the results in both INR and Seconds. Because the meter does not report liquid control results in seconds, it is necessary to run the precision study as patient samples in order to report in seconds. You have the option of storing them with a unique ID that distinguishes them from actual patient results in the meter s memory (e.g. 123ABC). In addition, the letter C will appear after the number to distinguish it as a control. All results obtained from each QC run must be within the specified acceptable QC range. Refer to the QC range for the specific lot of controls that are being tested. Any QC out of range should be repeated to confirm the result. Use a new vial of control solution for each precision test unless you are dosing multiple meters at the same time. Acceptance Criteria: %CV is less than or equal to the total CV published in the package insert for the control level (1 or 2) you are using. Each QC result must be within the assigned range. (See instructions below for Steps to Calculate QC Precision.) 26

32 PROCEDURE Testing Precision Using Liquid Controls 1. Set the meter to report the results in INR and SEC (seconds). 2. Prepare the controls according to Preparing the Control procedure in the Quality Control Testing section. 3. Slide the test strip as far as you can into the meter. This turns the meter ON. A beep tone indicates that meter has detected a test strip (provided the beeper is turned on in the settings). 4. Prepare the CoaguChek XS Plus meter and log on according to Testing a Patient Sample procedure. 5. Touch PATIENT TEST. 6. The meter automatically checks to see if you have the right test strip code chip. The 3-digit code on the test strip container must match the number on the test strip code chip before the test can be run. 7. The hourglass symbol shows that the test strip is warming up. 8. The test strip and blood drop symbol flashes to indicate that the meter is ready to perform the test and is waiting for the control solution to be applied. A 180-second countdown begins. You must apply the control sample within this time. Otherwise, you will receive an error message. 9. When the meter is ready for the sample, gently swirl the control bottle once or twice to mix the control solution. DO NOT mix the solution with the dropper. 10. Draw control solution into the dropper and put one drop of the liquid on the top of the target area (clear area of the test strip). DO NOT add more control. DO NOT touch or remove the test strip while the test is in progress. 11. The flashing test strip and blood drop symbols change to an hourglass symbol when the meter detects sufficient sample. You hear a beep tone when you have applied enough control solution (provided the beeper is turned on). The dropper symbol disappears and the test starts. 12. You must WAIT for results this takes about one minute. 13. The result of the quality control test followed by a C is displayed. It is automatically saved to PATIENT RESULT memory. 14. Record the control value in seconds on the Precision Data Log for Liquid Quality Control, which is found in the log sheet section of this manual. 15. Properly discard the used test strip according to this facility s infection control policy. 16. Run control tests using a new bottle of control solution for each of the remaining Level 1 and Level 2 controls for a total of 10 tests for each level. Record results. 27

33 17. Properly discard control vials according to this facility s infection control policy. 18. Calculate the mean, standard deviation, and coefficient of variation (%CV) in seconds. You may use standard calculators or spreadsheet programs for this calculation, or you many use the Steps to Calculate QC Precision section of this manual. PROCEDURE Steps to Calculate QC Precision 1. Repeat any tests where the QC result was outside the acceptable range. 2. On the Precision Data Log for Liquid QC, calculate and record the mean for Level 1 in Column B. 3. Subtract the mean (Column B) from each value in Column A and record this difference in Column C. 4. Square each difference and record in Column D. 5. Sum the squared differences and record. 6. Divide the sum of the squared differences by the total number of observations. 7. Find the square root of the sum of step 6. Note: This is a pooled standard deviation (SD) that should represent the amount of variability that you would expect between replicates done on the same patient. 8. Divide the SD from step 7 by the mean from step 2. This is the %CV that should represent the amount of variability that you would expect between replicates done on the same patient, expressed as a percentage. Record this value. 9. Repeat steps 1-8 for Level 2 CoaguChek XS Pro PT Controls. 28

34 POLICY Method Comparison Method comparison is not a CLIA requirement for waived test systems, but may be performed in order to compare test results from a new method to a previous method. Controls must be within acceptable range before running patient samples. Reference method controls must also be within the range specified by the manufacturer or laboratory. Specimens consist of 40 samples total 30 from patients on warfarin therapy evenly distributed with as broad a PT as possible, and 10 from healthy patients who fit the following criteria: not on warfarin nonsmokers not on aspirin or any other medication that affects clotting time Note: For method comparison, we recommend that no patients whom are on heparin therapy be enrolled in the study. A minimum of 40 data points is necessary for a correlation study. CoaguChek XS Plus System results will be compared to a laboratory reference method. Differences in reagents, instruments, and pre-analytical variables can affect PT results. These factors should be considered when comparing different prothrombin time test methods. 1 Experience comparing results obtained using the CoaguChek XS Plus System to those obtained using common clinical laboratory reagents shows that the CoaguChek XS Plus System correlates well with the following clinical laboratory reagents: Dade Innovin, Ortho Recomboplastin, and Dade Thromboplastin C+. NOTE: It s possible other clinical laboratory reagents may not consistently correlate with the CoaguChek XS Plus System as well as the recommended list above. When performing method comparison testing, it is important to ensure proper technique is followed in testing with both methods. When the study is complete, please fax results to the attention of Roche Diagnostics Technical Service at The results will be calculated and returned within three business days. A reference lab should be certain to follow appropriate PT testing guidelines. Some common sources of error include: Specimen collection: Incorrect volume, type, or concentration of anticoagulant in the collection tube. The anticoagulant used should be 106 to 109 mmol/l, 3.13% to 3.2% of the dihydrate form of trisodium citrate, buffered or nonbuffered. Other anticoagulants are unacceptable. 29